Safety/Efficacy of Induction Agents With Tacrolimus, MMF, and Rapid Steroid Withdrawal in Renal Transplant Recipients
INTAC
Phase 4, Randomized, Open-label, Comparative, Multicenter Study to Assess the Safety and Efficacy of Induction Agents, Alemtuzumab, Basiliximab or Rabbit Anti-thymocyte Globulin in Combination With Tacrolimus, MMF, and a Rapid Steroid Withdrawal in Renal Transplant Recipients
1 other identifier
interventional
501
1 country
29
Brief Summary
The purpose of this study is to compare the safety and efficacy of different induction agents (alemtuzumab, basiliximab or rabbit anti-thymocyte globulin) in renal transplant recipients treated with tacrolimus, mycophenolate mofetil (MMF) and a rapid steroid withdrawal.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2005
Longer than P75 for phase_4
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 7, 2005
CompletedFirst Posted
Study publicly available on registry
June 8, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedResults Posted
Study results publicly available
July 8, 2011
CompletedAugust 11, 2011
August 1, 2011
3.8 years
June 7, 2005
June 7, 2011
August 9, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient Incidence of Biopsy-confirmed Acute Rejection (BCAR) at 6 Months
A BCAR is a suspected new rejection w/in 6 mos. of skin closure, confirmed by Banff Grade ≥1A assigned by a pathologist. The Banff 97 classification system is used for interpreting histology of allograft biopsies, including Mild (1A/1B), Moderate (2A/2B) \& Severe (3). Kaplan Meier analysis was used to estimate % of pts. w/event. Patients w/no event at time of scheduled visit or whose 1st event was after premature discontinuation of study drug/tacrolimus were censored on the scheduled day of a) assessment, b) of premature treatment discontinuation or c) last evaluation, whichever came 1st.
6 months
Secondary Outcomes (10)
Overall Patient Incidence of BCAR
End of Study (36 months)
Efficacy Failure
End of Study (36 months)
Clinically Treated Acute Rejection
End of Study (36 months)
Time to First BCAR
End of Study (36 months)
Graft Survival at 12 Months
12 months
- +5 more secondary outcomes
Study Arms (4)
Alemtuzumab High-Risk Patients
EXPERIMENTALAlemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
Conventional High-Risk Patients
ACTIVE COMPARATORRabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
Alemtuzumab Low- Risk Patients
EXPERIMENTALAlemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \< 20% and first transplant and non-African American
Conventional Low-Risk Patients
ACTIVE COMPARATORBasiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \< 20% and first transplant and non-African American
Interventions
oral
Intravenous (IV)
oral
IV and/or oral
Eligibility Criteria
You may qualify if:
- Recipient of a primary or re-transplanted deceased donor kidney or a primary or re-transplanted non-human leukocyte antigen (HLA) living donor kidney (ie., HLA identical or 0 antigen mismatch deceased donor kidneys are allowed).
You may not qualify if:
- Patient has previously received an organ transplant other than a kidney
- Patient receiving chronic steroid therapy at time of transplant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
Unknown Facility
Birmingham, Alabama, 35294, United States
Unknown Facility
Los Angeles, California, 90057, United States
Unknown Facility
Palo Alto, California, 94304, United States
Unknown Facility
San Diego, California, 92123, United States
Unknown Facility
San Francisco, California, 94115, United States
Unknown Facility
San Francisco, California, 94143, United States
Unknown Facility
Denver, Colorado, 80262, United States
Unknown Facility
Washington D.C., District of Columbia, 20007, United States
Unknown Facility
Washington D.C., District of Columbia, 20010, United States
Unknown Facility
Miami, Florida, 33136, United States
Unknown Facility
Tampa, Florida, 33066, United States
Unknown Facility
Chicago, Illinois, 60611, United States
Unknown Facility
Chicago, Illinois, 60612, United States
Unknown Facility
Livingston, New Jersey, 07039, United States
Unknown Facility
New Brunswick, New Jersey, 08901, United States
Unknown Facility
Hawthorne, New York, 10532, United States
Unknown Facility
New York, New York, 10029, United States
Unknown Facility
New York, New York, 10032, United States
Unknown Facility
Chapel Hill, North Carolina, 27599, United States
Unknown Facility
Durham, North Carolina, 27710, United States
Unknown Facility
Cincinnati, Ohio, 45267, United States
Unknown Facility
Portland, Oregon, 97239, United States
Unknown Facility
Danville, Pennsylvania, 17822, United States
Unknown Facility
Harrisburg, Pennsylvania, 17105, United States
Unknown Facility
Charleston, South Carolina, 29425, United States
Unknown Facility
San Antonio, Texas, 78229, United States
Unknown Facility
Salt Lake City, Utah, 84132, United States
Unknown Facility
Madison, Wisconsin, 53792, United States
Unknown Facility
Milwaukee, Wisconsin, 53226, United States
Related Publications (1)
Hanaway MJ, Woodle ES, Mulgaonkar S, Peddi VR, Kaufman DB, First MR, Croy R, Holman J; INTAC Study Group. Alemtuzumab induction in renal transplantation. N Engl J Med. 2011 May 19;364(20):1909-19. doi: 10.1056/NEJMoa1009546.
PMID: 21591943BACKGROUND
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Company makes no warranties or representations of any kind as to the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose, and shall not be liable for any damages.
Results Point of Contact
- Title
- Senior Medical Director
- Organization
- Astellas Pharma Global Development
Study Officials
- STUDY DIRECTOR
Central Contact
Astellas Pharma Global Development
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 7, 2005
First Posted
June 8, 2005
Study Start
May 1, 2005
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
August 11, 2011
Results First Posted
July 8, 2011
Record last verified: 2011-08